FDA 510(k)

AccuCath Intravascular Catheter

K-Number: K162894 · 2016-11-15

Decision Date2016-11-15

Product CodeFOZ

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

AccuCath Intravascular Catheter is the device name listed in this FDA 510(k) record. The listed applicant is C.R. Bard, Inc.. It received FDA 510(k) clearance on 2016-11-15 under 510(k) number K162894. The device is classified under product code FOZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AccuCath Intravascular Catheter?

AccuCath Intravascular Catheter is a medical device that received FDA 510(k) clearance on 2016-11-15. The listed applicant is C.R. Bard, Inc.. The 510(k) number is K162894.

When did AccuCath Intravascular Catheter receive FDA 510(k) clearance?

AccuCath Intravascular Catheter received FDA 510(k) clearance on 2016-11-15, under 510(k) number K162894.

Who is the listed applicant for AccuCath Intravascular Catheter?

The FDA 510(k) record lists C.R. Bard, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AccuCath Intravascular Catheter?

The FDA product code for AccuCath Intravascular Catheter is FOZ.

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Related Devices (Code: FOZ)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.